Evidence map›Paper›PMID 29373987›Full record

Trial reportTrials2018

Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

Anna M Johnson, Sara B Jones, Pamela W Duncan, Cheryl D Bushnell, Sylvia W Coleman, Laurie H Mettam, Anna M Kucharska-Newton, Mysha E Sissine, Wayne D Rosamond

Registry-linked trialOpen access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02588664 (Early Supported Discharge for Improving Functional Outcomes After Stroke), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02588664 nacompletednot on this map

Early Supported Discharge for Improving Functional Outcomes After Stroke

TypeinterventionalSponsorWake Forest University Health SciencesRan2016 to 2020Enrolled6,024ConditionsStroke, Transient Ischemic AttackArmsCOMPASS Intervention
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

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  16. Recruitment challenges in stroke neurorecovery clinical trials.Contemporary clinical trials communications · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Anna M JohnsonDepartment of Epidemiology, University of North Carolina Gillings School of Global Public Health, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC, 27599-7435, USA. anna.johnson@unc.edu.
Sara B JonesDepartment of Epidemiology, University of North Carolina Gillings School of Global Public Health, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC, 27599-7435, USA.
Pamela W DuncanDepartment of Neurology, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Cheryl D BushnellDepartment of Neurology, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Sylvia W ColemanDepartment of Neurology, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Laurie H MettamDepartment of Epidemiology, University of North Carolina Gillings School of Global Public Health, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC, 27599-7435, USA.
Anna M Kucharska-NewtonDepartment of Epidemiology, University of North Carolina Gillings School of Global Public Health, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC, 27599-7435, USA.
Mysha E SissineDepartment of Neurology, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Wayne D RosamondDepartment of Epidemiology, University of North Carolina Gillings School of Global Public Health, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC, 27599-7435, USA.
University of North Carolina at Chapel Hill · USWake Forest University · US

Funding

Wake Forest Clinical and Translational Science AwardUL1TR001420 · NCATS · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ARD, JAMY D, FOLEY, KRISTIE L · 2015 to 2023
$32.3M
National Center for Advancing Translational Sciences (US) UL1TR001420NCATS NIH HHS UL1 TR001420Patient-Centered Outcomes Research Institute PCS-1403-14532; NCT02588664
6 · The paper itself

Abstract

backgroundPragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study.

methodsThe COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies.

resultsWe successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board administrators.

conclusionsAlthough we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials.

trial registrationClinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.

Indexed as

Delivery of Health Care, IntegratedHospitalsPatient SelectionStroke RehabilitationCaregiversCost of IllnessHumansIschemic Attack, TransientNorth CarolinaPatient ReadmissionStress, PsychologicalTime FactorsTreatment OutcomeClinical trialCluster-randomizedHospital recruitmentPost-acute carePragmaticStroke

Identifiers

PMID29373987
PMCPMC5787294
OpenAlexW2785186488

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.